Prescription medicine
Rituximab Brand names: Riabni, Ruxience, Rituxan, Truxima
Rituximab (Rituxan) is a prescription medicine with an FDA approval on record since 1997. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the rituximab FDA label on DailyMed (effective January 6, 2025, Genentech, Inc.); the BLA 103705 record on Drugs@FDA; every rituximab label on DailyMed.
Highlights of the record
FDA label of January 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS.
REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1), Adverse Reactions (6.1) ]. […]
Used for
From the label: indications and usageRITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ).
Forms and strengths
- 10 mg/ml
- 100 mg/10ml
- 500 mg/50ml
Injection (solution).
On the market
- Earliest approval on file
- November 26, 1997 Rituxan, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 4 of which 0 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 219,890 through July 30, 2026
What is rituximab used for?
From the label: indications and usageRITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. […]
Conditions named in the indications of rituximab's FDA labels, with every medicine labeled for each:
From other rituximab labelsRheumatoid arthritis: Arthritis (RA) RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
FDA pharmacologic class: CD20-directed Cytolytic Antibody.
Source: FDA drug label (Rituxan), Genentech, Inc., effective January 6, 2025 (SPL set b172773b-3905-4a1c-ad95-bab4b6126563), via openFDA; the full label on DailyMed
What does the patient leaflet for rituximab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about RITUXAN?RITUXAN can cause serious side effects that can lead to death including: Infusion-related reactions. Infusion-related reactions are very common side effects of RITUXAN treatment. Serious infusion-related reactions can happen during your or your child's infusion or within 24 hours after your or your child's infusion of RITUXAN. Your healthcare provider should give you or your child medicines before your or your child's infusion of RITUXAN to decrease your or your child's chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms during or after an infusion of RITUXAN: hives (red itchy welts) or rash itching swelling of your lips, tongue, throat or face sudden cough shortness of breath, difficulty breathing, or wheezing weakness dizziness or feel faint palpitations (feel like your heart is racing or fluttering) chest pain Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms at any time during your treatment with RITUXAN: painful sores or ulcers on your skin, lips or in your mouth blisters peeling skin rash pustules Hepatitis B virus (HBV) reactivation. Before you or your child receive RITUXAN treatment, your healthcare provider will do blood tests to check for HBV infection. If you or your child have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. You or your child should not receive RITUXAN if you or your child have active hepatitis B liver disease. […]
Source: FDA drug label (Rituxan), Genentech, Inc., effective January 6, 2025 (SPL set b172773b-3905-4a1c-ad95-bab4b6126563), via openFDA; the full label on DailyMed
Is there a generic for rituximab (Rituxan)?
No generic rituximab is approved (Drugs@FDA, October 8, 2026).
- 1997 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has rituximab been recalled?
The FDA's Enforcement Report lists 1 recall naming rituximab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the rituximab label say about other medicines?
The rituximab label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name rituximab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | Premedicate patients with an antihistamine and acetaminophen prior to dosing. |
| Cisplatin | drug interactions | Renal toxicity when used in combination with cisplatin ( 5.8 ). |
| Cyclophosphamide | drug interactions | In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. |
| Epinephrine | warnings and precautions | Institute medical management (e.g., glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. |
| Fludarabine | drug interactions | In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. |
| Methotrexate | drug interactions | In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab. |
| Methylprednisolone | warnings and precautions | For RA, GPA and MPA, and PV patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. |
| Prednisone | warnings and precautions | For pediatric patients with mature B-cell NHL/B-AL, administer prednisone as part of chemotherapy regimen prior to RITUXAN during induction and as needed for subsequent cycles [see Dosage and Administration (2.2 and 2.8) ]. |
Other labels that name rituximab
Source: FDA drug label (Rituxan), Genentech, Inc., effective January 6, 2025 (SPL set b172773b-3905-4a1c-ad95-bab4b6126563), via openFDA; the full label on DailyMed
What do FAERS reports show for rituximab?
The FDA Adverse Event Reporting System holds 219,890 reports that list rituximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 37,918 are coded as a death and 70,125 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as rituximab?
36 other medicines are given the same way (intravenous) and in the same FDA class as rituximab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Obinutuzumab | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to rituximab
- 36 medicines for the same use
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Rituximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other